Systems and methods for delivering targeted therapy

Abstract

A computer-assisted medical device is configured and used to endoluminally navigate to a location in the gastrointestinal system and there treat certain body lumen wall areas while avoiding other body lumen wall areas. Embodiments ablate the inner mucosal layer and sub-mucosal nerve plexus of the stomach, duodenum and jejunum to effect treatment of insulin resistance and metabolic disorders, such as Type II diabetes (T2D), polycystic ovarian syndrome (PCOS), non-alcoholic steatohepatitis (NASH), non-alcoholic fatty liver disease (NAFLD), congestive heart failure (CHF) and obstructive sleep apnea (OSA). Various sensors are used to assist a clinical operator to navigate from the mouth through the pyloric sphincter and into and through the duodenum and/or jejunum. Various sensors are used to map and identify portions of the duodenum and/or jejunum. Various lumen wall ablation devices and methods are described. Various post-treatment assessments are described.

1 - 17 . (canceled) 
     
     
         18 . A medical system for positioning a medical device within a body lumen, the medical system comprising:
 the medical device comprising a distal end portion, an expandable member;   at least one alignment sensor; and   a control system operably coupled to the medical device and the at least one alignment sensor, wherein the control system comprises a processing system and a memory system operatively coupled to the processing system, the memory system including programmed instructions adapted to cause the processing system to perform operations comprising:   detecting, via the at least one alignment sensor, alignment of the distal end portion of the medical device with an anatomic structure;   expanding the expandable member to contact a wall of the body lumen to align the distal end portion of the medical device with a longitudinal centerline of the body lumen; and   advancing the medical device a total insertion distance.   
     
     
         19 . The medical system of  claim 18  further comprising a rigidizing system, wherein the control system is further operatively coupled to the rigidizing system, and wherein the operations further comprise:
 rigidizing the distal end portion of the medical device using the rigidizing system. 
 
     
     
         20 . The medical system of  claim 19 , wherein the operations further comprise collapsing the expandable member after rigidizing the distal end portion of the medical device. 
     
     
         21 . The medical system of  claim 18 , wherein advancing the medical device includes inserting a fixed distance, the fixed distance being an incremental distance of the total insertion distance. 
     
     
         22 . The medical system of  claim 21 , wherein the operations further comprise:
 relaxing the distal end portion of the medical device after the medical device is inserted the fixed distance; and   after relaxing the distal end portion, repeating the detecting of the alignment of the distal end portion of the medical device with the anatomic structure, the expanding of the expandable member, and the advancing of the medical device the incremental distance until the medical device has advanced the total insertion distance.   
     
     
         23 . The medical system of  claim 18 , wherein the at least one alignment sensor includes at least one navigation sensor configured to detect at least one of a proximity of the distal end portion of the medical device to the anatomic structure, a force between the medical device and the anatomic structure, or a misalignment with a desired orientation along a desired path within the body lumen. 
     
     
         24 . The medical system of  claim 23 , wherein the navigation sensor comprises a capacitive strain gauge, a fiber bragg sensor, a semiconductor, an electromagnetic sensor, a gravity sensor, an acoustic sensor, or an accelerometer. 
     
     
         25 . The medical system of  claim 18 , wherein the at least one alignment sensor includes at least one imaging sensor configured to detect a proximity of the distal end portion of the medical device to the anatomic structure. 
     
     
         26 . The medical system of  claim 25 , wherein the imaging sensor comprises an endoscopic camera, an ultrasound device, a fiberscope, or an optical coherence tomography device. 
     
     
         27 . The medical system of  claim 18 , wherein the anatomic structure is the body lumen and the at least one alignment sensor is configured to detect a fluid meniscus to determine a proximity of the distal end portion of the medical device to the body lumen. 
     
     
         28 . The medical system of  claim 18 , wherein the anatomic structure is a body sphincter and the at least one alignment sensor include a pH sensor for detecting a pH gradient across the body sphincter. 
     
     
         29 . The medical system of  claim 28 , wherein the advancing of the medical device includes inserting the distal end portion of the medical device towards a direction of the pH gradient. 
     
     
         30 . The medical system of  claim 18 , wherein the anatomic structure is a body sphincter and the at least one alignment sensor include a pressure sensor for detecting a pressure gradient across the body sphincter. 
     
     
         31 . The medical system of  claim 30 , wherein the advancing of the medical device includes inserting the distal end portion of the medical device towards a direction of the pressure gradient. 
     
     
         32 . The medical system of  claim 18 , wherein the expandable member comprises at least one balloon and wherein the expanding of the balloon is automatically triggered based on detecting a misalignment of the medical device with the anatomic structure. 
     
     
         33 . The medical system of  claim 19 , wherein the distal end portion of the medical device being rigidized is near the expandable member. 
     
     
         34 . The medical system of  claim 18 , wherein the medical device further comprises at least one ablation element for ablation of the wall of the body lumen. 
     
     
         35 . The medical system of  claim 18 , further comprising a steering mechanism coupled to the control system, wherein the operations further comprises positioning the distal end portion of the medical device within the body lumen to align the distal end portion with the anatomic structure. 
     
     
         36 . The medical system of  claim 18 , further comprising a user input device coupled to the control system, wherein the total insertion distance is based on input provided through the user input device. 
     
     
         37 . The medical system of  claim 18 , further comprising a user interface for providing user guidance based on the detecting of a misalignment of the medical device with the anatomic structure, wherein the user guidance is at least one of visual, audible, or haptic guidance. his listing of claims will replace all prior versions, and listings, of claims in the application: